RE104 Clinical Lactation Study

A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

Inclusion Criteria:

• Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
• Has been breastfeeding or actively pumping for at least 4 weeks postpartum
• Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
• Willing and able to pump in order to maintain sufficient milk supply volumes for the study
• Is not pregnant or planning to become pregnant during the study
• Able to understand and adhere to study schedule and requirements and willing to sign an ICF
• In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening

Exclusion Criteria:

• Has mastitis or other condition that would prevent the collection of milk from one or both breasts
• Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
• Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
• Has used or intends to use of prohibited medications
• Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications